VA Lessons From Partnering in COVID-19 Clinical Trials
Background: The US Department of Veterans Affairs (VA) Office of Research and Development (ORD) supports an extensive clinical trials enterprise. Until recently, external partnerships were limited. The VA’s potential value as a partner became more apparent during the COVID-19 pandemic because of its large health care system, diverse patient population, and expertise in conducting clinical trials.
Observations: By leveraging its infrastructure, the VA was able to participate in 7 large-scale COVID-19 therapeutic and vaccine trials. A key aspect of this enterprise approach is the ability to provide centralized direction and coordination. The VA’s partnerships with external groups offered insights into the challenges associated with conducting important trials, especially when rapidity and coordination were essential. The ORD also developed solutions for reducing study startup time that could be established as best practices. We offer lessons for the challenges VA faced: site infrastructure needs and capabilities; study management roles and responsibilities; educational resources; local review; study design demands; contracting and budgeting; central-level systems; and communication.
Conclusions: VA participation in major COVID-19 therapeutic and vaccine trials represented a significant part of its research response to the pandemic. These contributions extended beyond the participants, scientists, and data that helped inform subsequent regulatory approvals. The VA also had an opportunity to directly develop partnerships with non-VA groups. These groups became more familiar with the VA while enabling us to gain more experience in the diverse practices used to conduct multisite clinical studies. Ultimately, these efforts empower the VA to further serve the broader scientific and clinical communities.
Internal and External Communication
The value of communication—both internal and external—cannot be understated. Minimizing confusion, managing expectations, and ensuring consistent messaging were essential for rapid trial execution. Despite being the second largest federal agency, the VA did not have a seat at the study leadership table for several protocols. When it joined later, several study aspects were set and/or difficult to revise. Challenges affecting time and securing resources have been noted. The ability to plan and then share expectations and responsibilities across and within the respective participating organizations early in the process was perhaps the single factor that was most addressable. The VA enterprise organization and integration with other units could accentuate key communications that would be essential in time-sensitive activities.
VA as a Partner for Future Research
Before the pandemic, the VA had already undertaken a path to enhance its ability to partner as part of the national biomedical research enterprise. The need for COVID-19 therapeutic and vaccine trials accelerated opportunities to plan and develop processes and capabilities to advance this path. As a key strength for VA scientific activities, clinical trials represent a primary medium by which to develop its partnerships. Learning and development have become part of a culture that expedites opportunities for veterans who actively seek ways to contribute to medical knowledge and treatments for their peers and the nation.
CONCLUSIONS
Challenges associated with rapid startup and completion of clinical trials have been discussed for some time. During the pandemic, needs and barriers were magnified because of the heightened urgency for evidence-based therapeutics and vaccines. While the VA faced similar problems as well as those specific to it as a health care system, it had the opportunity to learn and more systematically implement solutions to help in its partnered efforts.10 As an enterprise, the VA hopes to apply lessons learned, strategies, and best practices to further its goals to enhance veteran access to clinical trials and respond to any future need to quickly establish evidence bases in pandemics and other health emergencies that warrant the rapid implementation of research.
Acknowledgments
The activities reported here were supported by the US Department of Veterans Affairs, Office of Research and Development.
